Job Title: Quality Engineer (Compliance) – Medical Devices Location: Cambridge, UK (Hybrid) Job Type: Contract About the Project A global biopharma organisation is expanding its Devices Centre of Excellence in Cambridge, UK. We are seeking an experienced contract Quality Engineer (Compliance) to support advanced medical device and drug–device combination product programmes. This is a hands-on, consultative contract role embedded within product development teams, ensuring design controls and risk management activities are completely audit-ready across the lifecycle from early development to clinical supply. Key Responsibilities & Measurable Goals Design Controls & Risk Management (Target: 100% compliance across DHF/RMF deliverables) * Lead design control and risk management activities for assigned programmes, ensuring deliverables are accurate, approved, and maintained. * Support and facilitate risk management workshops with external design and manufacturing partners. * Provide quality engineering input into design validation activities, including Human Factors Engineering (HFE) and usability assessments. Regulatory Compliance & Auditing (Target: Zero major audit non-conformances) * Ensure strict compliance with key standards and regulations, including ISO 13485, ISO 14971, 21 CFR 820, and EU MDR. * Assess external partners and suppliers for QMS capability, compliance, and regulatory readiness. ...